[Federal Register Volume 70, Number 148 (Wednesday, August 3, 2005)]
[Notices]
[Pages 44672-44673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-15343]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Treatment of Inflammatory 
Diseases Using Ghrelin

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
an exclusive license to practice the invention embodied in U.S. 
provisional patent application, S/N 60/569,819 filed May 11, 2004, 
entitled ``Methods for Inhibiting Proinflammatory Cytokine Expression 
Using Ghrelin'' and converted to PCT on May 11, 2005 (E-016-2004/0-PCT-
02), [Inventors: Vishwa D. Dixit, Dennis D. Taub, Eric Schaffer, and 
Dzung Nguyen (NIA)], to Gastrotech Pharma (hereafter Gastrotech), 
having a place of business in Copenhagen, Denmark. The patent rights in 
these inventions have been assigned to the United States of America.

DATES: Only written comments and/or application for a license, which 
are received by the NIH Office of Technology Transfer on or before 
October 3, 2005 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Sally Hu, Ph.D., M.B.A., Office of Technology 
Transfer, National Institutes of Health, 6011 Executive Boulevard, 
Suite 325, Rockville, MD 20852-3804; Email: [email protected]; 
Telephone: (301) 435-5606; Facsimile: (301) 402-0220.

SUPPLEMENTARY INFORMATION: E-016-2004/0-US-01 provides methods for 
treating inflammation by inhibiting pro-inflammatory cytokine 
expression using Ghrelin, or a fragment thereof. Inflammation could be 
caused by a variety of viral, bacterial, fungal, or parasitic 
infections. The invention also provides methods for treating loss of 
appetite, and sepsis. Ghrelin, a naturally occurring peptide hormone 
was shown to be the ligand for growth hormone secretagogue receptor 
(GHS-R), and is mainly produced by the epithelial cells in the stomach. 
Ghrelin exerts many important actions in the body, including 
stimulation of growth hormone secretion, induction of appetite, and 
regulation of energy expenditure. Ghrelin directly controls human 
growth hormone and insulin growth factor expression by human immune 
cells. The inventors showed that Ghrelin exerts anti-inflammatory 
effects by inhibiting the secretion of acute and chronic cytokines, 
including IL-1, IL-6, TNF-[alpha], IFN-[gamma], IL-12, chemokines, and 
CSF in vitro and in vivo mouse models of sepsis and inflammation. This 
invention can be useful for treatment of various inflammatory 
disorders, including inflammatory bowel disease, Crohn's disease, 
rheumatoid arthritis, multiple sclerosis, atherosclerosis, endotoxemia, 
and graft-versus-host disease. It can also be used as a treatment for 
loss of appetite and sepsis.
    The prospective exclusive license will be royalty bearing and will 
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. 
The prospective exclusive license may be granted unless, within 60 days 
from the date of this published Notice, NIH receives written evidence 
and argument that establishes that the grant of the license would not 
be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
    The field of use may be limited to the use of Ghrelin as a novel 
drug to treat a range of inflammatory diseases.
    Properly filed competing applications for a license filed in 
response to this notice will be treated as objections to the 
contemplated license. Comments

[[Page 44673]]

and objections submitted in response to this notice will not be made 
available for public inspection, and, to the extent permitted by law, 
will not be released under the Freedom of Information Act, 5 U.S.C. 
552.

    Dated: July 19, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-15343 Filed 8-2-05; 8:45 am]
BILLING CODE 4140-01-P